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Walgreens chap aid regular lip balm - Prescription Drug Labeling

Product NDC Code 0363-0927
Drug Name

Walgreens chap aid regular lip balm

Type Brand
Active Ingredients
Padimate o 15 mg/g
Petrolatum 450 mg/g
Route TOPICAL
Dosage Form STICK
Application Number part352
Labeler Name Walgreen Company
Packages
Package NDC Code Description
0363-0927-01 4.3 g in 1 tube (0363-0927-01)
0363-0927-03 60 tube in 1 jar (0363-0927-03) > 4.3 g in 1 tube

Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredients Padimate O 1.5% Petrolatum 45%

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions • apply liberally 15 minutes before sun exposure • use a water resistant sunscreen if swimming or sweating • reapply at least every 2 hours • children under 6 months: ask a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients camphor, carnauba wax, cetyl alcohol, D&C red #6 barium lake, fragrance, isopropyl lanolate, isopropyl myristate, lanolin, methylparaben, mineral oil, paraffin, propylparaben, white wax

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses helps prevent sunburn and chapped lips

Purpose

Information about the drug product’s indications for use.
Purpose Padimate O - Sunscreen Petrolatum - Skin protectant

Spl product data elements

Usually a list of ingredients in a drug product.
Walgreens Chap Aid Regular Lip Balm Padimate O, Petrolatum PADIMATE O PADIMATE O PETROLATUM PETROLATUM CAMPHOR (SYNTHETIC) CARNAUBA WAX CETYL ALCOHOL D&C RED NO. 6 ISOPROPYL MYRISTATE LANOLIN METHYLPARABEN MINERAL OIL PARAFFIN PROPYLPARABEN WHITE WAX

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Principal Display Panel Drug Facts

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do not use on damaged or broken skin

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
Other Information protect this product from excessive heat and direct sun

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions? 1-800-WALGREENS (1-800-925-4733)

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask a doctor if rash occurs

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
When using this product keep out of eyes. Rinse with water to remove.

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging. For external use only Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.

Disclaimer: Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API